Articles

Test License to Manufacture for Test, Evaluation and Clinical Investigation of Medical Devices

by Divya S. Content Writer

Medical devices capture a large chunk of the pharmaceutical market, and are responsible for assisting doctors in assessing or curing a situation. However, since these devices are concerned with the health of a human being. They need to undergo proper investigation and trials before being released into the market.

According to the Medical Device Registration India, such devices are classified into four categories. A, B, C and D.

The classification is done based upon the level of risk associated with their use. For example, a Class A medical device can be as simple as a bandage or wheelchair , whereas a Class D medical device can be as complex as a pacemaker.

Either way, each medical device being introduced in the Indian market has to obtain the appropriate license to manufacture for test, evaluation and clinical investigation.

The process can be taken further to Medical Device Regulation India, once the tests and investigations are deemed satisfactory by the authorities.

Applying for a test license can be cumbersome at times, due to the effort and time to be involved with it. However, it is always a good choice to hire a clinical trial registration consultant in India.

Let’s take a brief overview of this registration process.

The application for obtaining a test license for trials and investigation  has to be made to the central licensing authority at CDSCO, New Delhi.

It is filed using form MD-12 which shall be properly filled and attached with the supporting documents.

Some important documents required for the application process include a detailed cover letter mentioning the purpose of the medical device and the overview of the manufacturing process. Along with supporting initial research, work procedures, and the information about components used for manufacturing.

Furthermore, the applicant is also required to submit a justification document describing the quantity of medical devices his/her company wants to manufacture. The approval of the application depends crucially upon this justification document.

It is also important to note that different class of medical devices have different levels of complexity associated with their approval. Seeking the help of a qualified medical device license consultant can greatly improve your chances of getting an approval.

 Class Is defined as the lowest risk class, Class B Low moderate risk class, Class C Moderate to high risk class and Class D High Risk Class.

For example Class A Bandage or wheelchair

 Test License

 To manufacture medical device for the purpose of Test, evaluation, examination, demonstration, training or clinical investigation


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About Divya S. Advanced   Content Writer

28 connections, 1 recommendations, 104 honor points.
Joined APSense since, November 26th, 2017, From Delhi, India.

Created on Oct 23rd 2019 04:35. Viewed 353 times.

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